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Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the topoisomerase I inhibitor deruxtecan (a derivative of exatecan). It is licensed for the treatment of breast cancer, non-small cell lung cancer (NSCLC), gastric or gastroesophageal adenocarcinoma. Trastuzumab binds to and blocks signaling through epidermal growth factor receptor 2 (HER2/neu) on cancers that rely on it for growth. Additionally, once bound to HER2 receptors, the antibody is internalized by the cell, carrying the bound deruxtecan along with it, where it interferes with the cell's ability to make DNA structural changes and replicate its DNA during cell division, leading to DNA damage when the cell attempts to replicate itself, destroying the cell.
Read the full article on WikipediaMetastatic (Stage IV) HER2 positive breast cancer Clinical criteria: Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription, AND The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; OR The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy, AND Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1, AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication, AND The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only. Treatment criteria: Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions. Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription: 1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable). 2) Details of prior HER2 directed drug regimens prescribed for the patient. 3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable). Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
Unresectable and/or metastatic HER2-low breast cancer Clinical criteria: Patient must have evidence of human epidermal growth factor receptor 2 (HER2)-low disease, AND Patient must have received prior chemotherapy in the metastatic setting; OR Patient must have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy, AND Patient must have received or be ineligible for endocrine therapy in the metastatic setting, if hormone receptor positive, AND Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1, AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication, AND The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only. Treatment criteria: Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions. HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH). Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription: 1) Evidence of HER2-low status 2) Details of prior drug regimens prescribed for the patient 3) Cardiac function test results Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
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